Implant system and method for bulking tissue

ABSTRACT

A system for placing an implant in the body includes an elongated member having at least one inner lumen extending from a proximal end portion of the member to an opening in a distal end portion of the member. At least one compressible implant is in the inner lumen of the member. The implant optionally includes anchor members projecting from its outer surface to limit migration of the implant in the body. Structure is provided to push the implant through the opening in the distal end portion of the member.  
     The implant is placed between layers of body tissue to bulk the tissue. In one of the disclosed methods, the system is used to treat gastroesophageal reflux disease (GERD) by placing the implant between layers of body tissue at or near the gastro-esophageal junction.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to an implant and a system andmethod for placing the implant in the body to bulk body tissue. Moreparticularly, the present invention relates to a system and method forplacing the implant at or near the gastro-esophageal junction to treatgastroesophageal reflux disease (GERD).

[0003] 2. Description of Related Art

[0004] The lower esophageal sphincter is located in a distal portion ofthe esophagus adjacent to the junction between the esophagus and thestomach. When food is digested, a properly functioning lower esophagealsphincter allows food to pass from the esophagus to the stomach whilelimiting reverse flow of the stomach contents into the esophagus.

[0005] Gastroesophageal reflux disease (GERD) is a disorder in which thelower esophageal sphincter allows contents of the stomach includinggastric acid and bile to reverse flow into the distal portion of theesophagus. Complications associated with GERD include heartburn,pulmonary disorders, chest pain, esophageal ulcers, esophagitis,Barrett's esophagus, and esophageal carcinoma.

[0006] A common treatment for GERD includes administering prescriptionacid blockers for limiting gastric production of acid. Although thesedrugs may provide short term relief, the drugs merely alleviate some ofthe symptoms of GERD rather than correcting the underlying dysfunctionof the lower esophageal sphincter. In addition, acid blockers areexpensive, and any long term complications associated with using acidblockers are unknown.

[0007] Various surgical procedures have been attempted to correct GERD.In one surgical procedure, known as Nissen fundoplication, a portion ofthe gastric fundus is wrapped around the esophagus. The wrapped gastricfundus applies pressure to the esophagus to limit reverse flow of thestomach contents into the esophagus. Conventional fundoplicationprocedures are effective at treating GERD, but they have a number ofdisadvantages. Open procedures require a large incision to expose thestomach and the lower esophagus. In laparoscopic procedures, four orfive smaller incisions are formed in the abdominal wall to insertinstruments into the body of the patient. However, such procedures areexpensive and sometimes require a significant amount of time for patientrecovery.

[0008] Some other procedures, such as those disclosed in U.S. Pat. No.5,403,326 and in U.S. Pat. No. 5,571,116, use surgical staples to securethe fundus of the stomach and the lower esophagus. However, some of therelatively rigid stapling instruments used in these procedures maydamage tissue when they are moved in a patient. In addition, such rigidinstruments are inserted into the operative field with trocar typedevices which make abdominal wall penetrations. These abdominal wallpenetrations increase the risks of post-operative hernias, accidentalorgan perforations, or other drawbacks associated with laparoscopicsurgery.

[0009] Bulking the tissue of the digestive track at or below thegastro-esophageal junction is a relatively recent, investigativetreatment for GERD. In one such treatment, collagen in a saline carrieris placed in the tissue around the gastro-esophageal junction to causepartial closure of the distal end of the esophagus and thereby preventgastric acid from reaching the esophageal mucosa. Although the collagencould provide short term benefits, it eventually becomes absorbed by thebody and loses it effectiveness.

[0010] Bulking of body tissue is also performed in a number of othertreatments and procedures. For example, tissue is bulked in cosmeticsurgical procedures and in treatments for urinary incontinence. However,the current implants and devices for inserting them have a number ofdisadvantages when they are used for tissue bulking.

[0011] In light of the foregoing, there is a need in the art for animproved implant, implantation system, and tissue bulking procedure.

SUMMARY OF THE INVENTION

[0012] Accordingly, the present invention is directed to an implant,system and method that substantially obviate one or more of thelimitations of the related art. To achieve these and other advantagesand in accordance with the purpose of the invention, as embodied andbroadly described herein, the invention includes a system for placing animplant in the body. The system comprises an elongated member and atleast one compressible implant in an inner lumen of the member. Theimplant is configured to be implanted in body tissue to bulk the tissue.Structure is provided for pushing the implant through an opening in adistal end portion of the member.

[0013] In an aspect of the invention, the structure for pushing theimplant includes a pushing member movable in the inner lumen or a sourceof fluid for pressurizing the inner lumen.

[0014] In another aspect, the elongated member has a first lumen for theimplant and a second lumen for passing fluid into the body to separatetissue layers.

[0015] In still another aspect, the implant includes structure forlimiting migration of the implant in the body.

[0016] In a further aspect, the present invention includes a method ofbulking tissue. In this method, the elongated member is introduced inthe body. The distal end portion of the elongated member is positionedbetween layers of body tissue. A pushing force is applied to the implantto move the implant through the opening in the distal end portion andbetween the layers of body tissue.

[0017] In yet another aspect, the method includes placing fluid betweenthe layers of body tissue to separate the layers of body tissue.

[0018] In an even further aspect, a plurality of compressible implantsare in the inner lumen of the elongated member, and more than one of thecompressible implants are placed between the layers of tissue.

[0019] In one other aspect, the implant is placed between body tissuelayers at or near the gastro-esophageal junction to treat GERD.

[0020] In an additional aspect, the present invention includes animplant formed of compressible material. Anchor members project from theouter surface of the implant. The anchor members are configured tointerconnect with anchor members on another implant implanted in thebody.

[0021] It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary, andare intended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention. In the drawings,

[0023]FIG. 1 is partial cross sectional view of an implant placementsystem according to a first embodiment of the invention;

[0024]FIG. 2 is a view similar to that of FIG. 1 with an implant of thesystem partially pushed through a distal end opening of an elongatedmember shown in FIG. 1;

[0025]FIG. 3 is a perspective view of one of the implants shown in FIGS.1 and 2;

[0026]FIG. 4 is a partial cross sectional view of a second embodiment ofthe implant placement system;

[0027]FIG. 5A is a cross sectional view taken along line 5-5 of FIG. 4;

[0028]FIG. 5B is a cross sectional view similar to that of FIG. 5Ashowing an alternative lumen configuration for an elongated member shownin FIG. 4;

[0029]FIG. 6 is a schematic view showing placement of implants in thegastro-esophageal junction during a GERD treatment procedure accordingto the invention;

[0030]FIG. 7 is a schematic cross sectional view taken along line 7-7 ofFIG. 6;

[0031]FIG. 8 is a schematic view similar to FIG. 6 showing the implantplacement without fluid for separating tissue layers;

[0032]FIG. 9 is a schematic view similar to FIG. 7 showing analternative GERD treatment procedure wherein implants are substantiallyparallel to the longitudinal axis of the esophagus;

[0033]FIG. 10 is a schematic cross sectional view taken along line 10-10of FIG. 9;

[0034]FIG. 11 is a view similar to FIG. 1 showing an embodiment of acurved implant insertion member;

[0035]FIG. 12 is a view similar to FIG. 3 showing an embodiment of theimplant having hook-shaped anchors;

[0036]FIG. 13 is a view similar to FIG. 3 showing an embodiment of theimplant having longitudinal ridges and grooves;

[0037]FIG. 14A is a cross-sectional view taken along line 14-14 of FIG.13 showing a first alternative ridge and groove shape for the implant ofFIG. 13;

[0038]FIG. 14B is a view similar to FIG. 14A showing a secondalternative ridge and groove shape;

[0039]FIG. 14C is a view similar to FIG. 14A showing a third alternativeridge and groove shape;

[0040]FIG. 15 is a view similar to FIG. 3 showing an embodiment of animplant having transverse ridges and grooves;

[0041]FIG. 16A is a partial cross-sectional view taken along line 16-16of FIG. 15 showing a first alternative ridge and groove shape for theimplant of FIG. 15;

[0042]FIG. 16B is a view similar to FIG. 16A showing a secondalternative ridge and groove shape; and

[0043]FIG. 16C is a view similar to FIG. 16A showing a third alternativeridge and groove shape.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numbers areused in the drawings and the description to refer to the same or likeparts, and similar reference numerals are used to refer to similarelements.

[0045]FIGS. 1 and 2 show an implant placement system 10 according to afirst embodiment of the invention. As shown in FIGS. 1 and 2, the system10 includes an elongated member 20 having an inner lumen 22, one or moreimplants 30 in the inner lumen 22, and a pushing member 40 for pushingthe implants 30 through both the lumen 22 and an opening 24 in a distalend portion of the elongated member 20.

[0046] The elongated member 20 is preferably a hollow needle, cannula,or tubular member having a sharpened distal end 26 configured to piercethough layers of body tissue so that the opening 24 can be positionedbetween the tissue layers. When the opening 24 is located in thisposition, one or more of the implants 30 are ejected from the opening 24and become implanted between the tissue layers. As described below, theelongated member 20 is preferably long enough to be passed transorallythrough the esophagus during a GERD treatment procedure to position thedistal end portion of the elongated member 20 between layers of tissueat or near the gastro-esophageal junction. To allow for such passagethrough the esophagus without significant trauma, the elongated member20 preferably has a sufficient amount of flexibility, and is optionallyprecurved or bent in a shape facilitating placement of the distal end 26at a desired location in the body. For example, FIG. 11 shows anembodiment of an elongated member 20A having a curved distal endportion.

[0047] The elongated member 20 could be formed of many different typesof material, but materials, such as radiopaque materials, which arecapable of being detected with conventional medical imaging equipment,are preferred. In a preferred embodiment, the elongated member 20includes bands or stripes of material capable of being visualized todetermine how far the elongated member 20 is inserted in the body.

[0048] The inner lumen 22 preferably extends from a proximal end 28 ofthe elongated member 20 to the opening 24 in the distal end 26. Thecross section of the inner lumen 22 could have many different shapes,however a generally circular cross sectional shape is preferred.Preferably, the surface of the inner lumen 22 is relatively smooth toallow for sliding of the implants 30 therethrough.

[0049] The pushing member 40 has an outer cross sectional size smallerthan the cross sectional size of the inner lumen 22 to allow the pushingmember 40 to move axially in the inner lumen 22. Preferably, the pushingmember 40 is a cylindrical-shaped push rod having a length slightlylonger than that of the elongated member 20. When at least one of theimplants 30 and the pushing member 40 are in the inner lumen 22, distalmovement of the pushing member 40 with respect to the elongated member40 forces the implants 30 through the inner lumen 22 and through thedistal end opening 24. To facilitate manipulating the pushing member 40and the elongated member 20, the proximal ends of both the pushingmember 40 and the elongated member 20 preferably include a respectivehandle (not shown).

[0050]FIG. 3 shows the preferred configuration of the implant 30. Theimplant 30 is preferably made of a flexible, compressible material,capable of being compressed into a reduced size permitting the implant30 to be stored in the inner lumen 22, and also permitting the implant30 to expand resiliently back to its original size after the implant 30passes through the distal end opening 24, as shown in FIG. 2. Becausethe implant 30 is capable of being compressed into a reduced size whileit is in the inner lumen 22, the outer cross sectional size of theelongated member 20 is reduced as compared to insertion devices fornon-compressible implants. Preferred materials for forming the implantinclude urethane, silicone, and fluoropolymer.

[0051] Preferably, the implant 30 is formed of open cell foam and/ orclosed cell foam having a number of internal void areas. The use ofclosed cell foam isolates antibody attack to the outer surface of thefoam to preserve the foam's flexibility and compressibility. Closed cellfoam also reduces significant tissue ingrowth to maintain theflexibility of the implant 30. Open cell foam, on the other hand,permits tissue and collagen growth in pores of the foam to reducemigration of the implant 30 in the body.

[0052] In an alternative embodiment, the implant 30 is formed of anelastomeric material and has a hollow cavity filled with a fluid, suchas air. Forming the implant 30 with such a material and cavity permitsthe implant 30 to be placed in the inner lumen 22 and to maintain itsshape after being implanted in the body without the need to be inflated.

[0053] To permit imaging of the implant 30, the implant 30 preferablyincludes radiopaque material capable of being detected with conventionalimaging equipment.

[0054] As shown in FIG. 3, the implant 30 preferably has a generallycylindrical shape with rounded ends. In another preferred embodiment(not shown), the implant 30 has a substantially spherical shape. Theimplant 30 could also be shaped in many other ways. For example, theimplant 30 could be have a polygonal shaped cross section, such as atriangular shaped cross section. When the implant 30 is cylindrical andin its expanded form, the implant 30 preferably has a length of fromabout 100 thousandths of an inch to about 250 thousandths of an inch,and a diameter of from about 50 thousandths of an inch to about 175thousandths of an inch, for example.

[0055] Preferably, the outer surface of the implant 30 includesstructure for limiting migration of the implant 30 when the implant 30is implanted in the body. In the embodiment of the implant 30 shown inFIG. 3, the implant 30 includes anchor members 32 extending from theouter surface of the implant 30. The anchor members 32 preferably have apointed or rounded end capable of engaging body tissue.

[0056]FIG. 12 shows an alternative embodiment of an implant 30A. Theimplant 30A includes anchor members 32A in the form of hook-shapedprojections. In addition to being configured to engage tissue, theanchor members 32A are also configured to interconnect withcorresponding hook-shaped projection anchors 32A on one or more otherimplants 30A to form coupled groups of the implants 30A. Optionally, theanchor members 32 and 32A are formed of a bioabsorbable material capableof being absorbed in the body after tissue growth around the implant 30,30A is sufficient.

[0057] The implant 30 could also include other structure for limitingmigration. For example, the implant 30 preferably includes an outersurface coating for increasing the coefficient of friction of theimplant 30. In addition, the outer surface of the implant 30 preferablyincludes ridges, grooves, or other surface discontinuities to reducemigration and to increase the outer surface area to induce tissueingrowth. For example, FIG. 13 shows an embodiment of an implant 30Bhaving longitudinal ridges 60 and grooves 62, and FIG. 15 shows anembodiment of an implant 30C having transverse ridges 64 and grooves 66.As shown in FIGS. 14A, 14B, and 14C, the implant 30B shown in FIG. 13could have pointed ridges 60A, rounded ridges 60B, or relativelyflattened ridges 60C, and either relatively flattened grooves 62A, 62Cor curved grooves 62B. As shown in FIGS. 16A, 16B, and 16C, the implant30C shown in FIG. 15 could have pointed ridges 64A, rounded ridges 64B,or relatively flattened ridges 64C, and pointed grooves 66A, roundedgrooves 66B or flattened grooves 66C.

[0058] There are many different ways in which the implants 30 could becompressed into a reduced size and loaded into the elongated member 20as shown in FIG. 1. One of the simplest ways of loading the implants inthe elongated member 20 is to force the implants 30 into the inner lumen22. In another process for loading the implants 30 in the elongatedmember 20, the implants 30 are reduced in size by clamping, heatshrinking, or stretching, and then the reduced size implants arecryogenically frozen. Optionally, when the implant is formed of opencell material, a soaking agent, such as water, is added to the foammaterial to facilitate reducing the implant's size prior to cryogenicfreezing. Soon after freezing, the chilled implants are placed in theelongated member 20 so that the implants 30 are capable of expandingwhen they are warmed.

[0059] Other methods of initially reducing the size of the implants 20and loading them in the elongated member 20 are possible. In onealternative method, a soaking agent is added to the implant, and theimplant is heat dried while it is maintained in a reduced size. The heatdrying causes the implant to remain in its reduced size until theimplant comes in contact with a liquid, such as water and expands like aconventional kitchen sponge. In another alternative embodiment, theimplant is placed in its reduced size by applying a vacuum to theimplant.

[0060]FIG. 4 shows an alternative embodiment of a system 10′ constructedsimilar to the system 10 shown in FIGS. 1 and 2. The system 10′ shown inFIG. 4 includes an elongated member 20′ having a first inner lumen 22′and a second inner lumen 23. Preferably, both the first inner lumen 22′and the second inner lumen 23 extend along the entire length of theelongated member 20′. The first inner lumen 22′ preferably extends froma proximal portion 28′ of the elongated member 10′ to a first opening24′ in a distal end 26′ of the elongated member 10′. The second innerlumen 23 preferably extends from the proximal portion 28′ to a secondopening 25 in the distal end 26′.

[0061] The first and second lumens 22′ and 23 could have many differentcross sectional shapes and sizes. As shown in FIG. 5A, the second lumen23 could have a substantially circular cross section and be positionedpartially within the first lumen 22′. Alternatively, as shown in FIG.5B, the second lumen 23 could have a generally flattened cross sectionalconfiguration.

[0062] Implants 30 are loaded in the first lumen 22′. To push theimplants 30 through both the first inner lumen 22′ and the first opening24′, the first lumen 22′ is preferably pressurized with fluid. As shownin FIG. 4, a first fluid source 50 is in fluid communication with thefirst inner lumen 22′. The first fluid source 50 is preferably a syringeor other pumping device capable of being activated to deliver a fluid,such as saline or air, to the first inner lumen 22′. When the fluiddelivered by the first source 50 increases the pressure in the firstinner lumen 22′, one or more of the implants 30 are forced through thefirst inner lumen 22′ and through the first opening 24′. If the ejectingfluid is a liquid and the implant 30 is formed of open cell foam, theimplant 30 preferably does not absorb an undue amount of the liquid.

[0063] In an alternative embodiment, not shown, a pushing member similaror identical to the pushing member 40 shown in FIGS. 1 and 2 is used inplace of the first fluid source 50 to eject implants 30 from the opening24′. In another alternative embodiment, not shown, the elongated member20 shown in FIGS. 1 and 2 has its inner lumen 22 in fluid communicationwith a fluid source, such as the first fluid source 50, rather thanhaving the pushing member 40.

[0064] As shown in FIG. 4, the second inner lumen 23 is preferably inflow communication with a second fluid source 52 similar or identical tothe first fluid source 50. The second fluid source 52 is configured todeliver fluid, such as saline, through both the second inner lumen 23and the second opening 25. As explained below, the fluid flowing fromthe second opening 25 is used to separate layers of body tissue when thedistal end 26′ is placed in the tissue. This separation of the layer ofbody tissue facilitates placement of the implants 30 between the tissuelayers.

[0065] Preferably, the fluid provided by the second source 52 includes aradiopaque additive, which is capable of being detected by conventionalradiographic imaging equipment. The use of the radiopaque additivepermits a physician to view the location of the tissue separationprovided by the fluid from the second source 52. In addition, thisadditive provides a visible radiographic background to allow for aphysician to determine whether the distal end of the elongated member10′ is properly located.

[0066] Methods of bulking tissue to treat GERD are discussed below withreference to FIGS. 1-4 and 6-10. Although the invention is described inconnection with the structure shown in these figures, and in connectionwith treating GERD, it should be understood that the invention in itsbroadest sense is not so limited.

[0067] Initially, the elongated member 10 shown in FIGS. 1 and 2 or theelongated member 10′ shown in FIG. 4 is introduced into the body of apatient until the distal end 26, 26′ of the elongated member 10, 10′ ispositioned at or near (for example, below) the gastro-esophagealjunction. To reduce trauma, the elongated member 10, 10′ is preferablypassed transorally through the esophagus until the distal end 26, 26′ isat or near the stomach. In a preferred practice of the invention, anendoscope, such as a gastro-intestinal endoscope having visual imagingcapability, is initially inserted transorally through the esophagus, andthe elongated member 10, 10′ is introduced through a working lumen ofthe endoscope. In order to facilitate insertion and positioning of theelongated member 10, 10′, the elongated member 10, 10′ is preferablypositioned while a physician uses imaging equipment, such asfluoroscopic, radiographic, ultrasonic, and/ or visual imagingequipment.

[0068] After the elongated member 10, 10′ is inserted in the esophagus,the distal end 26, 26′ of the elongated member 10, 10′ is positionedbetween layers of body tissue at or near the gastro-esophageal junction.When the distal end 26, 26′ includes a sharp tip, such as that shown inFIGS. 1, 2, and 4, the distal end 26, 26′ is pierced through the layersof body tissue.

[0069] As shown schematically in FIGS. 6-10, the tissue at or near thegastro-esophageal junction J includes three primary layers—the mucosalayer A which forms the inner lining of the esophagus E and stomach S,the submucosa layer B which is the intermediate tissue layer, and themuscularis layer C which is the outermost layer. Preferably, the distalend 26, 26′ shown in FIGS. 1, 2, and 4 is positioned so that the opening24, 24′ is located between the mucosa layer and the outer surface of themuscularis layer.

[0070] To facilitate proper positioning of the distal end 26, 26′between the appropriate tissue layers, fluid is preferably placedbetween the tissue layers to form a pocket that separates the layers oftissue. For example, when the elongated member 10′ shown in FIG. 4 isused, the fluid for separating the tissue layers is delivered throughthe second opening 25 by the second fluid source 52. When the elongatedmember 10 shown in FIGS. 1 and 2 is used, a separate needle is insertedinto the layers of tissue at or near the gastro-esophageal junction, andthe needle is used to inject fluid, like that delivered by the secondfluid source 52, between the tissue layers to separate them. Because theelongated member 10′ shown in FIG. 4 includes the second inner lumen 23,a separate needle or other structure is not required to separate thetissue layers with fluid.

[0071] After optionally separating the tissue with fluid to position thedistal end 26, 26′, one or more of the implants 30 are ejected from thedistal end opening 24, 24′ by pushing the implants 30 through both theinner lumen 22, 22′ and the opening 24, 24′. As the implants 30 arepushed through the opening 24, 24′, they expand from their compressedconfiguration, as shown in FIG. 2, for example.

[0072] The way in which the implants 30 are pushed through the opening24, 24′ depends on the particular structural arrangement being used.When the elongated member 20′ shown in FIG. 4 is being used, theimplants 30 are pushed through the opening 24′ by pressurizing the innerlumen 22′ with the fluid from the first fluid source 50. When theelongated member 20 shown in FIGS. 1 and 2 is being used, the implants30 are pushed through the opening 24 by moving the pushing member 40distally in the inner lumen 22 and/or by retracting the elongated member20 proximally with respect to the pushing member 40 while the pushingmember 40 contacts one of the implants 30 in the inner lumen 22.Retracting the elongated member 20 is preferred in certain circumstancesbecause the implants 30 are placed in the body at a location previousoccupied by the distal end 26.

[0073] Preferably, the implants 30 are placed between the mucosa layerand the muscularis layer at or near the gastro-esophageal junction. Theimplants 30 could be arranged in a uniform or random manner. Preferably,the implants 30 are placed in the submucosa layer, however, the implants30 may also be positioned in at least a portion of the muscularis layerand even the mucosa layer.

[0074] Preferably, more than one of the implants 30 is placed in thelayers of tissue adjacent to or at the gastro-esophageal junction,although it could be possible to place only a single implant 30 in thetissue. The exact number of implants 30 depends on a number of factorsincluding the expanded size of the implants 30 and the amount of tissuebulking which is required. Having a plurality of implants 30 loaded inthe lumen 22, 22′ limits the need to load more implants or introduceanother implant insertion device.

[0075] If the implants 30 include anchor members 32, such as those shownin FIG. 3, the anchor members 32 preferably limit migration of theimplants 32. When the implants include hook-shaped anchors, such as theanchors 30A shown in FIG. 12, the anchor members of adjacent implantscan be interconnected to form groups of multiple implants having limitedmigration.

[0076] FIGS. 6-8 show an example of how the implants 30-are preferablyplaced at multiple locations in the submucosa layer B located betweenthe esophagus E and stomach S and slightly below the gastro-esophagealjunction J. As shown in FIGS. 6-7, the implants 30 are placed so thatthe longitudinal axes of the implants 30 are in a plane substantiallyperpendicular to the longitudinal axis of the esophagus E. However,other configurations are possible. For example, FIGS. 9 and 10 show theimplants 30 placed in the tissue layers so that the axes of implants 30are substantially parallel to the axis of the esophagus E.

[0077] When the implants 30 are positioned, as shown in FIGS. 6-8, sothat the axes of the implants 30 are in a plane that is substantiallyperpendicular to the axis of the esophagus E, the elongated member 20,20′ is preferably curved or bent, for example, like the member 20A shownin FIG. 12, to facilitate placing the implants 30 in the tissue whilethe elongated member 20, 20′ extends along the esophagus E. For example,the elongated member 20, 20′ could have a bend or curve that positionsthe axis of the distal end portion of the elongated member 20, 20′ in aplane substantially perpendicular to the axis of the remaining portionof the elongated member 20, 20′ FIGS. 6 and 7 show the implants 30suspended in fluid F used to separate the layers of tissue. Preferably,the structure that was used to introduce this fluid F, such as thesecond opening 25, second lumen 23, and second fluid source 52, is alsoused to remove the fluid F to secure the implants 30 in place betweenthe tissue layers. Alternatively, the fluid F is absorbed into the body.FIG. 8 shows the placement of the implants 30 after the fluid is removedor absorbed.

[0078] Preferably the implants 30 bulk the tissue at or near thegastro-esophageal junction so that the bulked tissue assists the loweresophageal sphincter to limit reverse flow of stomach contents into theesophagus. Depending on the amount of bulking required, the implants 30do not always needs to be located directly at the gastro-esophagealjunction. Because the implants 30 are preferably compressible andflexible, they allow for relatively normal digestion. If necessary,additional implants 30 could be placed in the tissue at a later time toincrease bulking, or the implants 30 could be removed from the tissue inan endoscopic mucosectomy procedure.

[0079] Although the implant according to the invention is preferablyused to bulk tissue at or near the gastro-esophageal junction in a GERDtreatment procedure, the implant could be used to bulk many differenttypes body tissue in different types of procedures. For example, theimplant could be used to bulk tissue along the urinary tract in aurinary incontinence treatment.

[0080] It will be apparent to those skilled in the art that variousmodifications and variations can be made to the structure andmethodology of the present invention without departing from the scope orspirit of the invention. In view of the foregoing, it is intended thatthe present invention cover modifications and variations of thisinvention provided they fall within the scope of the following claimsand their equivalents.

What is claimed is:
 1. A system for placing an implant in the body,comprising: an elongated member having a proximal end portion, a distalend portion, at least one opening in the distal end portion, and atleast one inner lumen extending from the proximal end portion to theopening in the distal end portion; at least one compressible implant inthe inner lumen of the elongated member, the implant being configured tobe implanted in body tissue to bulk the tissue; and means for pushingthe implant through the opening in the distal end portion of theelongated member.
 2. The system of claim 1, wherein the pushing meanscomprises a pushing member movable in the inner lumen of the elongatedmember.
 3. The system of claim 1, wherein the pushing means comprises asource of fluid in fluid communication with the inner lumen, the sourceof fluid pressurizing the inner lumen to force the implant through theopening in the distal end portion of the elongated member.
 4. The systemof claim 1, wherein the elongated member is a needle having a distal endconfigured to pierce through tissue.
 5. The system of claim 1, whereinthe member comprises a first inner lumen and a second inner lumen, theimplant being in the first inner lumen and the second inner lumen beingin fluid communication with a source of fluid, fluid flowing through thesecond inner lumen being capable of separating layers of body tissue. 6.The system of claim 5, wherein the first inner lumen and the secondinner lumen each extend from the proximal portion to a respectiveopening in a distal end of the elongated member.
 7. The system of claim1, wherein a plurality of the implants are in the inner lumen.
 8. Thesystem of claim 1, wherein the implant is formed of material includingat least one of the group consisting of open cell foam and closed cellfoam.
 9. The system of claim 1, wherein the implant includes a hollowcavity and wherein the implant is formed of an elastomeric material. 10.The system of claim 1, wherein the implant is expandable from acompressed configuration to an expanded configuration, the implant beingin the compressed configuration when the implant is in the inner lumenand the implant expanding to the expanded configuration when the implantpasses through the opening in the distal end portion of the elongatedmember.
 11. The system of claim 1, wherein an outer surface of theimplant includes means for limiting migration of the implant in thebody.
 12. The system of claim 11, wherein the migration limiting meanscomprises anchor members extending from the outer surface of theimplant.
 13. The system of claim 12, wherein the anchor members areconfigured to interconnect with anchor members on another implantimplanted in the body.
 14. The system of claim 11, wherein the migrationlimiting means comprises a coating on the outer surface of the implantfor limiting sliding of the implant in the body.
 15. The system of claim11, wherein the migration limiting means comprises at least one of thegroup consisting of ridges and grooves formed on the outer surface ofthe implant.
 16. The system of claim 1, wherein the implant comprisesradiopaque material.
 17. A method of bulking tissue using an elongatedmember and at least one compressible implant in an inner lumen of theelongated member, comprising: introducing the elongated member in thebody; positioning a distal end portion of the elongated member betweenlayers of body tissue; and applying a pushing force to the implant tomove the implant through an opening in the distal end portion andbetween the layers of body tissue.
 18. The method of claim 17, whereinthe applying of the pushing force includes moving a pushing member inthe inner lumen toward the distal end portion to push the implantthrough the opening.
 19. The method of claim 17, further comprisingretracting the elongated member while the pushing force is applied tothe implant.
 20. The method of claim 17, wherein the applying of thepushing force includes pressurizing the inner lumen to force the implantthrough the opening.
 21. The method of claim 17, further comprisingpiercing the body tissue with a distal end of the elongated member. 22.The method of claim 17, further comprising placing fluid between thelayers of body tissue to separate the layers of body tissue.
 23. Themethod of claim 22, wherein the placing of fluid includes flowing thefluid from the elongated member into an area between the layers of bodytissue.
 24. The method of claim 22, wherein the placing of fluidincludes flowing the fluid from a needle into an area between the layersof body tissue.
 25. The method of claim 17, wherein the implant isexpandable from a compressed configuration to an expanded configuration,and wherein the method further comprises allowing the implant to expandto the expanded configuration when the implant passes through theopening in the elongated member.
 26. The method of claim 17, wherein aplurality of compressible implants are in the inner lumen of theelongated member, and wherein the method further comprises placing morethan one of the compressible implants between the layers of tissue. 27.The method of claim 26, wherein the implants include anchor memberscapable of interconnecting with one another, and wherein the methodfurther comprises interconnecting at least one of the anchor members onone of the implants with at least one of the anchor members on anotherof the implants to limit migration of the implants in the body.
 28. Themethod of claim 17, wherein the implant is placed between layers of bodytissue at or near the gastro-esophageal junction to treatgastro-esophageal reflux disease.
 29. The method of claim 28, whereinthe implant is elongated and has a longitudinal axis, and wherein themethod further comprises positioning the implant between the tissuelayers so that the longitudinal axis of the implant is substantiallyparallel to the longitudinal axis of the esophagus.
 30. The method ofclaim 28, wherein the implant is elongated and has a longitudinal axis,and wherein the method further comprises positioning the implant betweenthe tissue layers so that the longitudinal axis of the implant is in aplane perpendicular to the longitudinal axis of the esophagus.
 31. Themethod of claim 28, further comprising placing the implant between amucosa layer and an outer surface of a muscularis layer located at ornear the gastro-esophageal junction.
 32. The method of claim 28, whereinthe introducing of the elongated member comprises passing the elongatedmember transorally through the esophagus.
 33. The method of claim 17,wherein the implant is placed between layers of tissue along the urinarytract to treat urinary incontinence.
 34. An implant configured to beimplanted in the body to bulk tissue, the implant comprisingcompressible material allowing the implant to expand from a compressedconfiguration to an expanded configuration, the implant furthercomprising a plurality of anchor members extending from the outersurface of the implant, the anchor members being configured tointerconnect with anchor members on another implant implanted in thebody.
 35. The implant of claim 34, wherein the implant is formed ofmaterial including at least one of the group consisting of open cellfoam and closed cell foam.
 36. The implant of claim 34, furthercomprising a coating on the outer surface of the implant for limitingsliding of the implant in the body.
 37. The implant of claim 34, whereinthe implant comprises radiopaque material.
 38. The implant of claim 34,wherein the implant comprises longitudinal grooves and ridges.
 39. Theimplant of claim 34, wherein the implant comprises transverse groovesand ridges.
 40. The implant of claim 34, wherein the implant has a shapeconsisting of one of: a substantially cylindrical shape and asubstantially spherical shape.